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U.S. Department of Health and Human Services

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OTC Panel Submissions (Indices Only): 04 - Cough-Cold

CCABA Submission Chart
Volume Number
Submittor
Subject

040001

to

040004

Merck Chem. Division

Thomas Davis

Noscapine
040005 Chesebrough-Ponds Pertussin

040006

to

040009

McNeil Laboratories

Patrick H. Seay, Ph.D.

Co-Tylenol Cold Formula Tablets
040010 Monsanto Methapyrilene Hcl
040011 Creomulsion Co. Creomulsion

040012

to

040018

Pennwalt Allerest
040019 Smith Kline & French Ornex

040020

to

040021

Smith Kline & French Benzedrex
040021 Smith Kline & French Ornacol
040022 Ludens Cough Drops

040023

to

040025

Calgon Consumer Products

Jane Howell

Sucrets
040026

A.H. Robins Co.

Robitussin

Glyceryl guaiacolate
040027 Pennwalt Sinarest Tablets
040028    

040029

to

040046

Johnson & Johnson Sine-aid
040032 USV Pharmaceutical Corp. Liquiprin

040047

to

040055

Vicks Chemical Co. Nyquil Nighttime Cold Medicine

040056

to

040060

040060A

Vicks Chemical Co. Vicks Vapor Rub

040061

to

040063

Vicks Chemical Co. Vicks Cough Drop
040063 USV Pharmaceutical Corp. Vaponefrin/Asthmanefrin
040064 Vicks Chemical Co. Vicks Cough Syrup

040065

to

040066

Vicks Chemical Co. Vick Inhaler
040067 Vicks Chemical Co.

Vick Cough Silencer

Formula 44D Cough Syrup

040068 Vicks Chemical Co. Formula 44D Cough Syrup

040069

to

040070

Vicks Chemical Co. Sinex Nasal Spray

040071

to

040072

Vicks Chemical Co. Formula 44D Cough Discs

040073

to

040079

Vicks Chemical Co. Formula 44 Cough Mixture
040080

Father John Medicine

Gerald Donehue

Cough Syrup

040081

to

040083

Schering Corp.

Ken Brilhart

Coricidin

Chlor-Trimeton

Afrin

040084 Hoffman-LaRoche Romilar Syrup
040085 Hoffman-LaRoche Romilar Expectorant
040086 Hoffman-LaRoche Romilar HB Tablets
040087 Hoffman-LaRoche Romilar CF Syrup
040088 Hoffman-LaRoche Romilar CF Capsules
040089 Hoffman-LaRoche Romilar Cough and Cold Capsules
040090 Hoffman-LaRoche Children’s Romilar Syrup
040091 Hoffman-LaRoche Romilar CF 8-Hr. Syrup
040092 Hoffman-LaRoche Romilar Cough Discs
040093 Hoffman- LaRoche Romilar Chewable Cough Tablets
040094 Hoffman-LaRoche Romilar III
040095 Chesebrough-Ponds Pertussin Wild   Berry Cough Syrup
040096 Chesebrough-Ponds Pertussin Medicated Vaporizer
040097 Chesebrough-Ponds Pertussin Plus Nighttime Cold Medicine
040098 Knoll Pharm. Co. Verequad
040099 USV Pharmaceutical Corp. Arrestin
040100 USV Pharmaceutical Corp. Vaponefrin/Asthmanefrin
040102 Abbott Laboratories Quelidrine Cough Syrup
040103 Abbott Laboratories Calcidrine Syrup
040104 A.H. Robins Co. Robitussets Troches
040105 A.H. Robins Co.   Robitussin   PE  Syrup
040106 A.H. Robins Co. Robitussin DM Syrup
040107 Ciba-Geigy Corp. Otrivin Nasel Solution and Spray
040108

LaWall & Harrison

Donald Abbott

Troutman’s Cough Syrup
040109 The Dow Chemical Co. 2/G
040110 The Dow Chemical Co. Novahistine-Elixir
040111 The Dow Chemical Co. Novahistine
040112 The Dow Chemical Co. 2 G/DM
040113 The Dow Chemical Co. Novahistine Expectorant
040114 The Dow Chemical Co. Novahistine - Special Study Addendum
040115 The Dow Chemical Co. Novahistine Fortia
040116 Ives Labs. Inc. Cerose DM
040117 Ives Labs. Inc. Cerose
040118 The Mentholatum Co. Mentholatum Ointment
040119   Whitehall  Labs. Inc. Dondrill Anticough Tablets
040120   Whitehall  Labs. Inc. Dristan Capsules
040121   Whitehall  Labs. Inc. Primatene Asthma Tablets (P)
040122   Whitehall  Labs. Inc. Primatene Asthma Tablets (M)
040123   Whitehall  Labs. Inc. Dristan Nasal Mist and Vapor Spray
040124  Whitehall  Labs. Inc. Clear and dry Tablets
040125   Whitehall  Labs. Inc. Dristan Cough Formula Liquid
040126   Whitehall  Labs. Inc. Dristan Decongestant Tablets
040127   Whitehall  labs. Inc. Primetime and Bronitin Mist
040128   Whitehall  labs. Inc. Bronitin Tablets
040129 Ives Labs. Inc. Cerose Compond
040130 Ives Labs. Inc. Cetro-Cirose
040131 Warner-Lambert Co. Listerine Cough Control Lozenge
040132 Warner-Lambert Co. Super Anahist Decongestant Nasal Spray
040133 Warner-Lambert Co. Big 4 Cough Formula
040134 Warner-Lambert Co. Listerine Antiseptic Lozenge
040135 Warner-Lambert Co. Smith Brothers Cough Discs
040136 Warner-Lambert Co. Hall’s Cough Tablets
040137 Warner-Lambert Co. Listerine Cold Tablets
040138 Warner-Lambert Co. Super Anahist Decongestant Tablets
040139 Ciba-Geigy Privine Nasal Solution and Spray
040140 The Dow Chemical Co. Novahistine Melet
040141 Plough, Inc.   St. Joseph ’s Cough Syrup for Children

040142

to

040146

Merck/Calgon Consumer Products Sucrets Cold Decongestant Formula
040147 Dorsey Laboratories Dorcol Pediatric Cough Syrup
040148 Dorsey Laboratories Dor-C Tablets
040149 Dorsey Laboratories Chexit Tablets
040150 Dorsey Laboratories Triaminic Expectorant
040151 Dorsey Laboratories Triaminic Syrup
040152 Dorsey Laboratories Triaminicin Nasal Spray
040153 Dorsey Laboratories Triaminicin Tablets
040154 Dorsey Laboratories Triaminicol Cough Syrup
040155 Dorsey Laboratories TussagesicR Tablets and Suspension
040156 Dorsey Laboratories Ursinus Inlay Tabs
040157 Merck Sharp & Dohme Capsules & Elixer Propadrine
040158 Merck Sharp & Dohme Capsules & Elixer Propadrine
040159 Sterling Drug, Inc. Deka Cough Syrup
040160 Sterling Drug, Inc. Neo-Synephrine Elixir
040161 Sterling Drug, Inc. Breacol Cough Medicine
040162 Sterling Drug, Inc. Bronkaid Mist
040163 Sterling Drug, Inc. Breacol with Prylon Cough Medicine
040164 Sterling Drug, Inc. Synephicol Cough Syrup
040165 Sterling Drug, Inc. Recindal Cough Medicine
040166 Sterling Drug, Inc.

Bronkotabs

Bronkotabs HAFS

Bronkolixer

Bronkaid Tabs

040167 Sterling Drug, Inc. NTR, NTZ, NRT Nose Drops and Nasal Spray
040168 Sterling Drug, Inc. Neo-Synephrine Nose Drops & Nasal Spray
040169 Sterling Drug, Inc.

Neo-Synephrine

Asafen

Synephricol

040170 FDA Library Bibliography
040171 Chesebrough-Ponds Pertussin Cold-Team-24
040172 Norwich Pharmacal Co. Quadrin
040173 Norwich Pharmacal Co. Elixir Terpin Hydrate
040174 Norwich Pharmacal Co. Baby Cough Syrup
040175 Searle Laboratories Amodrine
040176 Pfizer Inc. Coryban-D Nasal Spray
040177 Pfizer Inc. Coryban-D Cough Syrup

040178

to

040189

Pfizer Inc. Coryban-D Cold Capsules
040190 The UpJohn Co.

Cheracol, Cheracol D

Cheracol Bilingual

040191 The UpJohn Co. Orthoxicol (Orthoxine Cough Syrup)

040192

to

040193

Miles labs. Alka Seltzer

040194

to

040197

A.H. robins  Co.

Dimetane Elixir

(Brompheniramine)

040198 The UpJohn Co. Pyrroxate Cap. And Tablets

040199

to

040200

Warner-Chilcott

Tedral

Tedral Anti-H

Tedral susp.

040201 UpJohn Co. Emeracol
040202 UpJohn Co. Terpin Hydrate and Codeine Elixir
040203 Block Drug Co. BC All Clear
040204

Key Pharm. Inc.

M. Friedland

Key Tusscapine
040205

Sandoz Pharmaceuticals

Div. Of Sandoz-Wander

Fiogesic Tablets
040206 R. Schiffman Co. Astmandor
040207 LaMay’s Asthmaeze, Inc. LaMay’s Asthmaeze
040208 F & F Laboratories, Inc. F & F Cough Lozenge
040209 E.R. Squibb & Sons, Inc. Spec-T Lozenges
040210 Reid Provident Labs. Reidacol Histelet Syrup, Histalet DM Syrup, PV tussin, Tusstrol, tusotrol DM, Coton Syrup
040211 Templetons Incorp. RAZ-MAH Greys Capsules
040212 Holford Co.  Holfords Inhaler, Indian Chief Inhaler
040213 FDA Summary of Submissions
040214    
040215

Colgate-Palmolive Co.

C.H. Costello

Congestaid RM Vaporizer
040216    
040217 Penick Glyceryl Guaiacolate
040218 Henry Thayer Co. Thayers Slippery Elm Throat Lozenges
040219 UpJohn Co. Hydriodic Acid
040220 UpJohn Co. Iodized Lime
040221 UpJohn Co. Special Formula #2
040222

UpJohn Co.

J.A. Jacob, M.D.

Cedicol (Cough Syrup),   Orange

040223

to

040224

Parke Davis & Co. Benylin
040225 Federal Register 18471 Revocation of Codeine Rx exemption
040226 Nat’l Analysts Inc. Summary of Health Practices
040227 Parke-Davis Benylin Expectorant
040228 Schering Co. Afrin Supplement
040229 E.R. Squibb & Sons Inc.

Spect-T Throat Spray

Spec-T Anesthetic Lozenge

040230 Sterling Drug, Co. Addition to Neo-Snyephrine
040231 Vicks Chemical Co. Inhaler
040232 Schering/Amendment Chlor-Trimeton
040433 Smith Kline & French Clorpheniramine
040434 Smith Kline & French Phenylpropanolamine
040235

Creomulsion Co.

V.O. Rankin

Beechwood Creosote
040236 Lilly Research Labs. Published articles re: Histadyl, methapyriline hydrochloride
040237 Chesebrough-Ponds Additional information on Pertussin Med. Vapor
040238 Bristol-Myers Safety of Sympathomimetic Drugs in Children 3-6 years
040239

Smith Kline & French

Cheston Simmons

Caramiphen Edisylate
040240 Pfizer Pharmaceuticals Toclase Syrup
040241

Pfizer Pharmaceuticals

Michael A. Hospador

Toclase Tablets
040242

Menley & James Labs.

Thomas W. Richards

Contac
040243

E.R. Squibb & Sons

Charles L. Kroll

Spec-T Anesthetic Lozenges

(New Formula-Revised)

040244

Warner/Chilcott

Chris P. Katsampes, M.D.

Tedral
040245

Smith Kline & French

Cheston Simmons

Ornacol Liquid and Capsules
040246

Sterling Drug, Inc.

B.G. Crouch, Ph.D.

Thenfadil
040247

Chesebrough-Ponds

Murry Berdick, Ph.D.

Pertussin Wild   Berry Cough Syrup
040248

Merck Sharp & Dohme

M. Jane Howell, M.D.

Sucrets
040249

Merck Sharp & Dohme

M. Jane Howell, M.D.

Sucrets
040250 Bristol-Myers Co. Nasel Decongestant Properties of Phenylpropanolamine
040251

Vick Division Research

Bob West, Ph.D.

Concomitancy of Colds Symptoms
040251A

Vick Division Research

Bob West, Ph.D.

Patient Reports
040252 Vick Division Research Topical Ephedrine
040253

Smith Kline & French

Cheston Simmons

Benzedrex Inhaler Study
040254 Sterling Drug, Inc. Breacol
040255

Vick Division Research

Bob West, Ph.D.

Supplemental - Formula 44
040256 UpJohn Co. Bronchodilators in Cough
040257

Vick Division Research

Bob West, Ph.D.

Vicks Cough Drops
040258

Chattem Drug & Chem. Co.

J.M. Holbert, Ph.D.

Theophylline sodium glycinate
040259 Smith Kline & French Caramiphen Edisylate

040260

to

040263

Wyeth Labs.

Wm. L. Langeland

Phenergan
040264

Vick Chemical Co.

Bob West, Ph.D.

Doxylamine (Decapryn) as an Antihistamine
040265

Parke-Davis

L.M. Lueck

Proposed study plan for Diphenhydramine Hydrochloride Pseudoephedrine Hydro.

040266

to

040271

Vicks Division Research

John B. Ward

Vaposteam
040272

Smith Kline & French

Cheston Simmon

Propylhexedrine
040273

Miles Labs.

Alfred S. Neely, IV

Phenylpropanolamine
040274

Richardson-Merrell

George Hoffnagle, M.D.

Doxylamine Succinate
040275

A.H. Robins

F.A. Clark, Jr.

Robitussin
040276

UpJohn Co.

Jay A. Nadel, M.D.

The Role of Bronchodilators in CCABA Products

040277

to

040278

Warner-Lambert Co.

Richard C. Brogle

Safety and Efficacy Review of OTC CCABA Products, Listerine Antiseptic
040279 Vick/Richardson Merrell Oil of Turpentine
040280

A.H. Robins

F.A. Clark

Suppl. Subm. To Clinical report of GG Robitussin

040281

to

040283

Hoffman-LaRoche

David Winer

Phenindomine tartrate

(Thephorin - Roche)

040284

Ciba-Geigy

Edward C. McKeen, M.D.

Otrivin (xylometazoline)

(hydrochloride NF) Nasal Solution and Spray

040285

Miles Labs.

Richard Shupack

Three Clinical Salts of Phenylpropanolamine
040286

Wyeth Labs.

Dr. D. Shaw

Antihistaminic Effectiveness of Promethazine
040287 Proprietary Association Supplemental Data on Combinations on the Market
040287A Proprietary Association Data on Combinations on the Market

040288A

040288B

  Whitehall  Labs.

Swenson/Behrman

Phenylephrine and Phenindamine
040289

Creomulsion Company

V.O. Rankin

Creomulsion Cough Medicine
040290 Vicks Division Research Ephedrine as Intranasal Decongestant
040291

Vicks Division Research

G. F. Hoffnagle

Literature on Xylometazoline
040292

Smith Kline & french

Arthur L. Davis

Cold, Cough, Allergy Bronchodilator & Anti-asthmatic Drugs
040293

Pennwalt Corp.

A. Lee Caldwell

Nonprescription drugs Timed Release dosage forms
040294

Smith Kline & French

Phiip Tannebaum

Caramiphene dislyate dosage Propylhexedrine Category I combinations
040295

Vick Division Reasearch

G. F. Hoffnagle

Alcohol

Vicks NYQUIL

040296

Vick Division Research

G. F. Hoffnagle

Combinations approval

Vicks Nyquil

040297

Vick Division Research

G. F. Hoffmangle

Antitussive with Antihistamine

Vicks Formula 44 Cough Mixture

040298 OTC Volume for References Unpublished data, Memos and Letters

040299A

040299B

Parke-Davis Presentation on Benylin
040300 Bristol-Myers Concerning Combo. Policy
040301 Wyeth Labs./AMHO Concomitance of Symptoms: Rhinorrhea & Cough
040302 Hoffman-LaRoche Activity of Commercial Anthistamines by an In Vivo Evaluation Method
040303 Proprietary Association Antihistamine Animal Tests
040304 Health Research Group Combo. Policy
040305 Pennwalt Corp. Presentation regarding Timed Release Dosage Forms

040306

to

040315

Vick/Richardson Merrell Supplement to Doxylamine succinate/Nov. 1974
040316 Hoffman-LaRoche Phenindamine (thephorin)
040317 Schiffman Asthmador
040318 AMHO/Wyeth Promethazine for allergy and in combo with Antitussive
040319 Wyeth Labs. Promethazine adverse Reactions
040320 Parke-Davis Benadryl/Antitussive
040321 Parke-Davis Benadryl/Antitussive Appendix A
040322 Vick Division Research Supplement to Vick Inhaler

040323A

040323B

FDA

FDA

Desi Reports

Desi Reports

040324 Wyeth Labs. Effectiveness of Promethazine
040325 FDA

Epidemiology Antihistamine

Toxline Search

040326

Parke-Davis

L. M. Lueck

Benylin Cough Syrup

(Benylin Expectorant)

040327 UpJohn Co. Bronchodilators in Cough/Nadel
040328 A. H. Robins Brompheniramine maleate
040329 Vick Division Research Antitussive, Analgesic-Antipyretic and Decongestant
040330 Vick Division Research Supplement to Vicks Nyquil submission
040331

Wyeth Labs.

Daniel L. Shaw

Promethazine hydrochloride

(Phenergan)

040332

Smith Kline & French

Cheston Simmons

Summary of data to support the drying action of antihistamines when prescribed for acute coryza (common cold) for relieve of CCABA Panel
040333

Warner-Lambert Co.

Richard C. Brogle

Thonzylamine (Neohetramine) and Phenyltoloxamine
040334

Warner-Lambert Co.

Richard C. Brogle

Warner Lambert Co. Products
040335 Vick Division Research Comments concerning dosage of specified dosage forms
040336 Vick Division Research Self-medication
040337

Ciba-Geigy

Edward C. McKeon

Nasal decongestants

Naphazoline & Xylometazoline

040338 NCI Study on Chloroform Report on Carcinogenicity
040339 Fisons Corp. Antitussives (noscapine)
040340 Parke-Davis Diphenhydramine
040341 Parke-Davis Diphenhydramine
040342 Vick Chemical Statement on DTC Cough/Colds principles applicable to combo. drugs
Top    

TFM VOLUME: 04BTFM  

Has been established for Bronchodilator  

Drug Products  

 

TFM VOLUME: 04CTFM  

Has been established for Anticholinergia  

Drug Products 

 

TFM VOLUME: 04HTFM  

Has been established for Antihistamine  

Drug Products  TFM VOLUME: 04NTFM  

Has been established for Nasal  Decongestant Drug Products

 Top